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Successful Commercialization Strategies for New Healthcare Products and Technologies

According to the Pharmaceutical Research and Manufacturers of America (PhRMA) more than 1,000 drugs are in various stages of development. Similarly, breakthroughs in the medical device arena such as coronary stents, implantable defibrillators, and minimally invasive bypass surgery and advances in DNA-based tests and other advanced diagnostics are detecting cancer and other diseases earlier when they are more treatable are moving from dream to reality.

It is obvious that even if all of these drugs and devices make it to market, not all will enjoy successful market penetration. With the average cost to develop a new drug exceeding $800 million, and at least $100 million for devices, companies have little choice but to improve the efficiency of their research, development, and commercialization processes.

Bringing new products to market under the conditions of the early 21st Century means that medical device, pharmaceutical, and biotechnology companies will have to demonstrate credible value for their products if they are to win in the marketplace. There are many aspects to this effort and each step in the process must be executed well if pitfalls downstream are to be avoided. The attitude of "build it and they will come" that was prevalent in the 1970s and 1980s played out in the 1990s and is no longer a viable strategy in 2003.

This new strategic report from Kalorama proposes a starting point and general roadmap for strategic marketing of new products and technologies in these highly competitive and cost conscious times.

The report examines specific cases of products that have or have not lived up to expectations and companies that have or have not been successful in their new product or technology introductions. The point of using these examples is not to highlight those companies that have failed but to use these instances to illustrate the intricacies and complexities of successful new product commercialization. They are also useful to alert readers to the fact that even the best plans may be the victims of unexpected reversals.

The overall premise proposed in this report is that successful product commercialization and market penetration is based on sound product development that incorporates at the outset:

1. a well defined philiosophy of product management, markets and marketing,

2. a systemic approach to defining and solving marketing problems, and

3. an awareness and understanding of key tools and and techniques necessary for effective marketing management.

The data and case studies presented in this report are derived from publicly available information sources such as company, government, professional organization reports, and from studies of successful programs published by various market research companies. The analysis is based on the author's expertise in marketing and industry knowledge combined with interviews with various industry participants in all areas and stages of life science product marketing.


Chapter One: Executive Summary

  • Scope and Methodology
  • Keys to Success
  • Case Summaries

Chapter Two: Introduction

  • Background
  • Crucial Keys to Successful New Product Commercialization
  • Point of View

Chapter Three: Strength Point One: Strategic Marketing Planning

  • Clinical Trial and Information Management
  • Distribution Strategies
  • Getting All the Ducks in a Row
  • Conclusion

Chapter Four: Strength Point Two: Managing Intellectual Property

  • Some IP and Patent Basics
  • Market exclusivity may be a myth
  • There are barriers to patent protection of biotech products
  • A gene patent is not always good for public relations
  • To Partner or Not To Partner?
  • Conclusion

Chapter Five: Strength Point Three: Managing the Regulatory Process

  • Overview of Regulatory Trends
  • United States
  • The Europe Union
  • Japan

Chapter Six: Strength Point Four: Assuring Product Reimbursement

  • Issues and Strategies
  • Conclusion

Chapter Seven: Strength Point Five: Managing the Product Life Cycle

  • Public Relations—Tell Your Story
  • Scale-Up Issues
  • Building a Supportive Organizational Structure

Chapter Eight: Strength Point Six: Managing Market Forces

  • Investors
  • Consumer Power
  • Scientific/Medical Community
  • Payors
  • Conclusion

Chapter Nine: Case Studies

  • Case I: Given Imaging Early Adopter Theory and Reimbursement Success—Mostly Right
  • Product Development
  • Product Extension
  • Reimbursement
  • Launch Strategy and Early Adopter Theory
  • Conclusion
  • Case II: Digene Corp. Focused on HPV—Maybe a Little Too Focused
  • A Chronology of Growth and Milestone Achievements
  • Following All the Early Adopter and Product Life Cycle Rules
  • Putting Distribution Networks in Place
  • Perhaps a Bit Too Late
  • Breaking into the Pap Test Business Through Connections
  • Failing to Develop Its Investment in a Pipeline Aside from HPV
  • Conclusion
  • Case III: Human Genome Sciences, Inc. Spin Doctor or Savvy Product Spinner—The Market Is Getting Impatient
  • The TIGR Deal
  • The Human Gene Therapeutic Consortium
  • Shrewd Investments for Quick Market Entry
  • The slide begins, investor confidence wanes
  • Conclusion

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